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Ainos, Inc.

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Business Summary

Ainos, Inc. is a dual-platform company focused on advancing artificial intelligence-based smelltech technologies and immune therapeutics. The company's primary strategic focus is the commercialization of its proprietary scent digitization platform, AI Nose, while also developing therapeutic assets based on its low-dose oral interferon program, VELDONA® . The AI Nose platform is an AI-based electronic olfaction system that integrates gas sensor arrays with proprietary artificial intelligence models, referred to as a smell language model ("SLM"), to digitize scent and volatile organic compound (VOC) signals into a machine-readable data format called Smell ID . VELDONA® is a low-dose oral interferon alpha formulation delivered to the oral cavity, designed to modulate immune responses .

The core business model revolves around generating revenue from sales of AI Nose hardware systems and recurring service-based offerings associated with its SmellTech platform . The company also generates revenue from VELDONA® Pet supplements and previously from COVID-19 Antigen Rapid Test Kits . Ainos operates with a capital-efficient model, primarily conducting research and development and certain operating functions in Taiwan, leveraging its position as a global technology supply chain hub and access to a skilled workforce . Manufacturing of AI Nose hardware and POCT product candidates is outsourced to Taiwan Carbon Nano Technology Corp. (TCNT), while VELDONA® human-use drug candidates are manufactured by Swiss Pharmaceutical Co., Ltd., and VELDONA® pet supplements by third-party manufacturers in Taiwan, including TCNT . Commercialization is supported by relationships with third parties such as Inabata & Co. Ltd., Topco Scientific Co., Ltd., Trusval Technology Co., Ltd., Solomon Technology Corporation, Kenmec Mechanical Engineering Co., Ltd., and Topmed International Biotech Co., Ltd. .

The AI Nose platform is designed to enable machines to detect, classify, and interpret scent and VOC signals in real time, translating complex scent signals into a structured, machine-readable data format . It is positioned as a connected, trainable SmellTech sensing platform with portable sensor hardware capable of parts-per-billion-level sensitivity, cloud connectivity, and proprietary AI models . Initially developed for healthcare-related settings like point-of-care testing (POCT) for ventilator-associated pneumonia, women's vaginal health, and sexually transmitted infections, its application has expanded into industrial environments such as semiconductor manufacturing, robotics, and smart manufacturing . The VELDONA® platform focuses on selected rare, autoimmune, and infectious disease indications, including oral warts in HIV-seropositive patients, Sjögren's syndrome, and feline chronic gingivostomatitis (FCGS) . The U.S. Food and Drug Administration has granted orphan drug designation for VELDONA® as a potential treatment for oral warts in HIV-seropositive patients .

For the fiscal year ended December 31, 2025, total revenues were $124,157 , a significant increase from $20,729 in 2024 . This increase was primarily driven by AI Nose related programs, which generated $123,360 in revenue in 2025, compared to nil in 2024 . Pet supplements contributed $797 in 2025, down from $20,321 in 2024 . The company ceased selling COVID-19 Antigen Rapid Test Kits in the first quarter of 2024, which had generated $408 in 2024 . Cost of revenues decreased to $21,246 in 2025 from $52,595 in 2024 , primarily due to the change in product mix. Gross profit for 2025 was $102,911 , a substantial improvement from a gross loss of $(31,866) in 2024 . Operating loss slightly increased to $13,990,408 in 2025 from $13,841,204 in 2024 . Net loss for 2025 was $14,771,012 , a slight decrease from $14,863,161 in 2024 . Diluted EPS was $(3.46) in 2025, compared to $(7.82) in 2024 . Cash and cash equivalents stood at $417,353 as of December 31, 2025, down from $3,892,919 at December 31, 2024 . Total liabilities were $13,308,526 in 2025, compared to $13,303,889 in 2024 .

During 2025, Ainos accelerated the transition of the AI Nose platform to early-stage commercialization, focusing on industrial and infrastructure-oriented applications . This included securing an initial commercial order of approximately $2.1 million over three years from a leading semiconductor packaging and testing customer for 1,400 AI Nose units . A collaboration with a Japanese service robotics partner led to pilot deployments of AI Nose across seven operational sites in Japan . In the VELDONA® program, clinical preparation and ongoing studies in Taiwan for oral warts in HIV-seropositive patients, Sjögren's syndrome, and FCGS were advanced . The company also marketed VELDONA® Pet supplements in Taiwan on a limited scale .

Business Outlook

Ainos's strategic outlook is centered on scaling the AI Nose platform as a SmellTech platform that digitizes scent as a machine-readable data modality . Following initial industrial validation in 2025, the company's priorities include expanding partner-led deployments, increasing scent data volume to refine the smell language model, and advancing commercialization through a combination of hardware sales and service-based offerings . Concurrently, Ainos plans to manage healthcare-related programs, including VELDONA®, in a selective and capital-efficient manner, with an emphasis on partnerships and out-licensing .

A major growth area for Ainos is the expansion of AI Nose into industrial environments, particularly semiconductor manufacturing, robotics, and smart manufacturing settings . The company secured an initial commercial deployment under a multi-year subscription agreement with a leading semiconductor packaging and testing company in 2025, totaling approximately $2.1 million over three years for 1,400 AI Nose systems . Additionally, a commercial arrangement with a semiconductor engineering and systems integration partner includes a contracted minimum order commitment of 600 AI Nose units for deployment in front-end wafer fabrication environments . Pilot deployments of AI Nose across seven operational sites in Japan through a collaboration with a Japanese service robotics partner are also underway to evaluate real-world performance and generate data for model refinement and commercial scaling . These deployments are expected to generate real-world scent data across diverse operating conditions, which will be used to refine models, improve classification performance, and broaden the range of detectable patterns, creating a data-driven feedback loop .

In the healthcare sector, Ainos continues to evaluate healthcare-adjacent use cases for AI Nose, including senior care hygiene monitoring, women's vaginal health, selected sexually transmitted infections, and environmental control and monitoring in hospital operations . For the VELDONA® therapeutic programs, the company is focusing on selected rare, autoimmune, and infectious disease indications such as oral warts in HIV-seropositive patients, Sjögren's syndrome, and feline chronic gingivostomatitis (FCGS) . Key clinical and partnering milestones for VELDONA® are currently expected to occur over the 2026–2027 timeframe, subject to regulatory review and study progress . The company intends to primarily pursue out-licensing and partnership opportunities to advance the further development and commercialization of the VELDONA® assets .

Ainos expects its research and development (R&D) expenses to continue to grow as it further develops AI Nose programs and VELDONA® drug candidates . The company's strategy emphasizes capital efficiency through a combination of geographic footprint, outsourced manufacturing, and third-party commercial relationships . Manufacturing of AI Nose hardware and POCT product candidates is outsourced to Taiwan Carbon Nano Technology Corp. (TCNT), and VELDONA® human-use drug candidates are manufactured by Swiss Pharmaceutical Co., Ltd. . The company also relies on third-party manufacturers in Taiwan, including TCNT, for VELDONA® pet supplement products .

For future liquidity, Ainos anticipates that cash reserves, business revenues, and potential debt financing through convertible and non-convertible notes will fund its operations over the next twelve months . The company expects primary uses of cash to fund operations as it continues to grow its business, requiring a significant amount of cash for working capital and capital expenditures to support the growth of its commercial infrastructure . Selling, general and administrative expenses and R&D expenses are expected to increase to support product development and commercialization roadmaps . The company also plans capital expenditures for investments in corporate facilities and equipment . From January 1, 2026, to March 30, 2026, the company sold 283,336 shares of common stock under an At-the-Market Offering Agreement, generating net proceeds of approximately $601,600 . Additionally, on March 27, 2026, Ainos entered into a loan agreement with ASE Test, Inc., a related party, for an aggregate principal amount of NT$90 million (approximately US$2,820,000) , bearing interest at 2.5% per annum, payable in full one year after the drawdown date .

Risk Factors

Ainos faces significant risks related to its limited operating history and financial position, including a history of operating losses that are expected to continue, with cumulative losses of $67,520,328 as of December 31, 2025 . The company has generated very little revenue from product sales and may never become profitable, being dependent on obtaining additional funding from outside sources, including the issuance of securities, to continue operations . The AI Nose platform is still under development and early commercialization, lacking a significant history of large-scale commercial adoption, recurring revenue, or long-term customer retention, making demand, pricing, renewal rates, and long-term profitability difficult to predict . The market for AI-enabled scent digitization and SmellTech solutions is nascent and may not develop as expected, or may adopt alternative technologies, limiting demand for AI Nose . The AI Nose platform may also fail to achieve acceptable accuracy, reliability, or performance across various use cases and environments, and may contain undetected errors, defects, or limitations that could impair adoption or result in liability . The performance of AI Nose relies on sufficient and effective data collection and model training, which may be insufficient or ineffective, and customers may be unwilling or unable to integrate AI Nose into existing systems or workflows . Expansion into industrial and other non-healthcare environments may expose AI Nose to new and unforeseen risks . The company's POCT and VELDONA® candidates are in early stages of clinical development, with uncertain outcomes, and their successful development and commercialization are critical to the business . Clinical product development is a lengthy, expensive, and uncertain process, with potential for delays due to regulatory hurdles, patient enrollment challenges, supply chain issues, or unforeseen events . Data from clinical trials conducted outside the United States, such as in Taiwan, may not be accepted by the FDA, requiring additional costly and time-consuming U.S.-based trials . Even if products receive marketing approval, they may fail to achieve market acceptance by physicians, patients, and third-party payors, or face unfavorable pricing regulations and reimbursement policies . Product liability lawsuits pose an inherent risk, potentially leading to substantial liabilities, decreased demand, reputational harm, and significant financial and management resource diversion . The company relies heavily on third-party components, cloud infrastructure, and manufacturers, increasing the risk of disruptions, errors, or insufficient supplies . Changes in or loss of third-party licenses could make software inoperable or reduce performance, leading to increased R&D costs or decreased demand . The pet health supplement and POCT markets are highly competitive and rapidly evolving, making it difficult to evaluate future prospects and potentially leading to price reductions, increased costs, reduced margins, and loss of market share . Research and development of drug candidates like VELDONA® is extremely expensive and complex, with no assurance of optimal balance between trial conduct, speed, and desired outcome, or that products will be competitive . The company's brand and product quality are crucial, and any failure to maintain them could lead to diminished brand value, adverse publicity, and negative financial impact . Health epidemics, such as COVID-19, could adversely affect business, operations, clinical development plans, timelines, and supply chains . Compliance with anti-bribery and anti-corruption laws, as well as export controls and trade sanctions, could limit the ability to compete in foreign markets and subject the company to liability . The company's common stock and warrants could experience wide fluctuations in market price due to various factors, including operating results, public float, and competition .

Management Priorities

Management's message to shareholders emphasizes a strategic focus on the commercialization and scaling of the AI Nose platform, while continuing to develop therapeutic assets based on the low-dose oral interferon program, VELDONA® . The primary strategic priorities include expanding partner-led deployments of AI Nose, increasing scent data volume to refine the smell language model, and advancing commercialization through a combination of hardware sales and service-based offerings . In parallel, management plans to manage healthcare-related programs, including VELDONA®, in a selective and capital-efficient manner, with an emphasis on partnerships and out-licensing . Management believes that cash on hand, anticipated net proceeds from product sales, and additional financing will fund operations over the short and medium terms based on the current plan . For the period from January 1, 2026, to March 30, 2026, the company sold 283,336 shares of common stock under the At-the-Market Offering Agreement, resulting in net proceeds of approximately $601,600 . Additionally, on March 27, 2026, the company entered into a loan agreement with ASE Test, Inc. for an aggregate principal amount of NT$90 million (approximately US$2,820,000) , bearing interest at 2.5% per annum, payable in full one year after the drawdown date .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Overview
  2. [2] Item 1, Business — Overview
  3. [3] Item 1, Business — Overview
  4. [4] Item 1, Business — Our Technologies
  5. [5] Item 7, MD&A — Revenues, Cost and Gross Loss
  6. [6] Item 1, Business — Our Business Model
  7. [7] Item 1, Business — Our Business Model
  8. [8] Item 1, Business — Our Business Model
  9. [9] Item 1, Business — Our Technologies
  10. [10] Item 1, Business — Our Technologies
  11. [11] Item 1, Business — Our Technologies
  12. [12] Item 1, Business — Our Technologies
  13. [13] Item 1, Business — Our Technologies
  14. [14] Item 7, MD&A — Results of Operations
  15. [15] Item 7, MD&A — Results of Operations
  16. [16] Item 7, MD&A — Revenues, Cost and Gross Loss
  17. [17] Item 7, MD&A — Revenues, Cost and Gross Loss
  18. [18] Item 7, MD&A — Revenues, Cost and Gross Loss
  19. [19] Item 7, MD&A — Revenues, Cost and Gross Loss
  20. [20] Item 7, MD&A — Revenues, Cost and Gross Loss
  21. [21] Item 7, MD&A — Revenues, Cost and Gross Loss
  22. [22] Item 7, MD&A — Operating Loss
  23. [23] Item 7, MD&A — Net Loss
  24. [24] Item 7, MD&A — Net Loss
  25. [25] Item 8, Consolidated Statements of Operations
  26. [26] Item 7, MD&A — Liquidity and Capital Resources
  27. [27] Item 8, Consolidated Balance Sheets
  28. [28] Item 7, MD&A — Key Developments in 2025
  29. [29] Item 7, MD&A — Key Developments in 2025
  30. [30] Item 7, MD&A — Key Developments in 2025
  31. [31] Item 7, MD&A — Key Developments in 2025
  32. [32] Item 7, MD&A — Key Developments in 2025
  33. [33] Item 7, MD&A — Strategy Outlook
  34. [34] Item 7, MD&A — Strategy Outlook
  35. [35] Item 7, MD&A — Strategy Outlook
  36. [36] Item 1, Business — Overview
  37. [37] Item 7, MD&A — Key Developments in 2025
  38. [38] Item 7, MD&A — Key Developments in 2025
  39. [39] Item 7, MD&A — Key Developments in 2025
  40. [40] Item 7, MD&A — Factors Affecting Our Business
  41. [41] Item 1, Business — Our Technologies
  42. [42] Item 1, Business — Our Technologies
  43. [43] Item 7, MD&A — Key Developments in 2025
  44. [44] Item 1, Business — Our Technologies
  45. [45] Item 7, MD&A — Research and Development (R&D) Expenses
  46. [46] Item 1, Business — Our Business Model
  47. [47] Item 1, Business — Our Business Model
  48. [48] Item 1, Business — Our Business Model
  49. [49] Item 7, MD&A — Liquidity and Capital Resources
  50. [50] Item 7, MD&A — Uses of Liquidity
  51. [51] Item 7, MD&A — Uses of Liquidity
  52. [52] Item 7, MD&A — Uses of Liquidity
  53. [53] Item 7, MD&A — Recent Financing
  54. [54] Item 9B, Other Information
  55. [55] Item 9B, Other Information
  56. [56] Item 1A, Risk Factors — Risks related to our limited operating history, financial position, and need for additional capital
  57. [57] Item 1A, Risk Factors — We have generated very little revenue from product sales and may never become profitable.
  58. [58] Item 1A, Risk Factors — AI Nose is a developing platform, and we may be unable to successfully generate meaningful revenue.
  59. [59] Item 1A, Risk Factors — The market for AI-enabled scent digitization and SmellTech solutions may not develop as we expect.
  60. [60] Item 1A, Risk Factors — AI Nose may fail to achieve acceptable accuracy, reliability, or performance across use cases and environments.
  61. [61] Item 1A, Risk Factors — The performance of AI Nose depends on data collection and model training, which may be insufficient or ineffective.
  62. [62] Item 1A, Risk Factors — Expansion into industrial and other non-healthcare environments may expose AI Nose to new and unforeseen risks.
  63. [63] Item 1A, Risk Factors — We are early in our development efforts of POCT and VELDONA candidates, and our business is dependent on the successful development of our current and future POCT and VELDONA candidates.
  64. [64] Item 1A, Risk Factors — Clinical product development involves a lengthy and expensive process, with uncertain outcomes.
  65. [65] Item 1A, Risk Factors — We and our collaboration partners have conducted and intend to conduct clinical trials for selected product candidates at sites outside the United States, and for any of our product candidates for which we seek approval in the United States, the FDA may not accept data from trials conducted in such locations or may require additional U.S.-based trials.
  66. [66] Item 1A, Risk Factors — Even if a current or future product candidate, including AI Nose, POCT and VELDONA, receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  67. [67] Item 1A, Risk Factors — If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of any approved products.
  68. [68] Item 1A, Risk Factors — Our reliance on third-party components and cloud infrastructure could disrupt AI Nose operations, and any errors, disruption, performance problems, or failure in their or our operational infrastructure could adversely affect our business, financial condition, and results of operations.
  69. [69] Item 1A, Risk Factors — We rely on the availability of licenses to third-party technology that may be difficult to replace or that may cause errors or delay implementation of our software and services should we not be able to continue or obtain a commercially reasonable license to such technology.
  70. [70] Item 1A, Risk Factors — As we are actively involved in marketing VELDONA Pet supplements within a fiercely competitive industry, any inability to effectively compete may adversely impact our operational results.
  71. [71] Item 1A, Risk Factors — Research and development of drug candidates such as VELDONA is extremely expensive and complex, and it’s difficult to evaluate the likelihood of the outcome of clinical trials, regulatory approvals, and our business and future prospects.
  72. [72] Item 1A, Risk Factors — If we fail to develop and maintain our brand, or the quality of our products that customers have come to expect, our business could suffer.
  73. [73] Item 1A, Risk Factors — Our business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of epidemics , including but not limited to COVID-19.
  74. [74] Item 1A, Risk Factors — Our business activities are subject to the Foreign Corrupt Practices Act, or the FCPA, and similar anti-bribery and anti-corruption laws of other countries in which we operate, including Taiwan, as well as U.S. and certain foreign export controls, trade sanctions, and import laws and regulations.
  75. [75] Item 1A, Risk Factors — An active trading market for our common stock may not develop, and the market price of our common stock and warrants could be volatile.
  76. [76] Item 7, MD&A — Overview
  77. [77] Item 7, MD&A — Strategy Outlook
  78. [78] Item 7, MD&A — Strategy Outlook
  79. [79] Item 1A, Risk Factors — Risks related to our limited operating history, financial position, and need for additional capital
  80. [80] Item 14, Subsequent Events
  81. [81] Item 9B, Other Information
  82. [82] Item 9B, Other Information

Analysis on 5/19/2026